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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000031224
Receipt No. R000035660
Scientific Title A clinical study to evaluate the effects of beverage containing green tea catechins on reducing LDL cholesterol
Date of disclosure of the study information 2019/02/09
Last modified on 2019/02/13

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Basic information
Public title A clinical study to evaluate the effects of beverage containing green tea catechins on reducing LDL cholesterol
Acronym A clinical study to evaluate the effects of beverage containing green tea catechins on reducing LDL cholesterol
Scientific Title A clinical study to evaluate the effects of beverage containing green tea catechins on reducing LDL cholesterol
Scientific Title:Acronym A clinical study to evaluate the effects of beverage containing green tea catechins on reducing LDL cholesterol
Region
Japan

Condition
Condition None
Classification by specialty
Not applicable Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the effects of the intake of beverage containing green tea catechins for 12 weeks on reducing LDL cholesterol
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes LDL cholesterol
Key secondary outcomes Total cholesterol, HDL cholesterol, LOX-index

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Intake of beverage containing green tea catechins for 12 weeks
Interventions/Control_2 Intake of placebo for 12 weeks
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
65 years-old >
Gender Male and Female
Key inclusion criteria 1) Subjects whose age of 20 years or more and less than 65 years
2) Subjects whose serum LDL cholesterol levels are 120 mg/dL or more and less than 140 mg/dL (borderline) or 140 mg/dL or more and less than 160 mg/dL (mild Hypercholesterolemia) in the screening examination
3) Subjects receiving a sufficient briefing of the objective and content of the present study, fully understanding and agreeing to voluntarily participate in the study and being able to personally sign a written informed consent
Key exclusion criteria 1) Subjects receiving a medical treatment for dyslipidemia
2) Subjects having serious hepatic, cardio-vascular, respiratory, endocrine or metabolic disorders
3) Subjects whose fasting serum triglyceride levels are 400 mg/dL or more
4) Subjects who have the possibility of developing allergic symptoms by the test food
5) Subjects who take Foods for Specified Health Uses or Foods with Function Claims labeled the effects of improving LDL cholesterol or total cholesterol levels
6) Subjects who take foods having the effects of improving LDL cholesterol or total cholesterol levels
7) Female subjects who are pregnant or lactating, or intending to be pregnant during the study
8) Female subjects who have menstrual irregularities
9) Subjects who have extremely irregular dietary habits, work in shifts or work during the night
10) Subjects having blood sample of 200 ml or more taken within 1 month, or 400 ml or more within 3 months prior to the start of the present study (e.g. donated blood)
11) Subjects who took part in another clinical study within 3 months prior to the start of the present study or who is currently taking part in another clinical study
12) Subjects deemed unsuitable by the investigator
Target sample size 140

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Takanobu Takihara
Organization ITO EN, Ltd.
Division name Central Research Institute
Zip code
Address 21 Mekami, Makinohara, Shizuoka
TEL 0548-54-1247
Email t-takihara@itoen.co.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Tomohiro Sugino
Organization Soiken Inc.
Division name Representative Director
Zip code
Address Senri Life Science Center 13F, 1-4-2, Shinsenri-higashimachi, Toyonaka, Osaka
TEL 06-6871-8888
Homepage URL
Email sugino@soiken.com

Sponsor
Institute Soiken Inc.
Institute
Department

Funding Source
Organization ITO EN, Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2019 Year 02 Month 09 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2017 Year 11 Month 18 Day
Date of IRB
Anticipated trial start date
2018 Year 02 Month 12 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 02 Month 09 Day
Last modified on
2019 Year 02 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035660

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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